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Community Based Screening for Colorectal Cancer in an Underserved High Risk Population in Nigeria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032874
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center, New York, USA
University College Hospital, Nigeria
University of Ilorin Teaching Hospital
Information provided by (Responsible Party):
Olusegun Alatise, Obafemi Awolowo University Teaching Hospital

Brief Summary:
Patient age 45 year old and above who presented with rectal bleeding at three tertiary hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the patients and the colonoscopy data were analyzed

Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Colonoscopy

Detailed Description:
Patient age 45 year old and above who presented with rectal bleeding at Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Nigeria, University College Hospital, Ibadan, Nigeria, and University of Ilorin Teaching Hospital, Ilorin Nigeria were invited for colonoscopy. Categorical variables were compared using χ2-test or Fisher's exact test while the Kruskal-Wallis test was used for quantitative variables. Multivariate analysis was performed using logistic regression model. All statistical tests were two-sided and p-values below 0.05 were considered statistically significant. Statistical analysis was carried out using SAS 9.4 and R 3.3.1.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colorectal Cancer Control in Low Resource Countries: Results From a Prospective Cohort Study of Patients at High-risk for Colorectal Cancer
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Training set
All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex
Procedure: Colonoscopy
They all had screening colonoscopy

Validation set
All the patients with rectal bleeding who had colonoscopy performed at University College Hospital, Ibadan and University of Ilorin Teaching Hospital
Procedure: Colonoscopy
They all had screening colonoscopy




Primary Outcome Measures :
  1. To determine colonoscopy polyp and cancer detection rate [ Time Frame: 2 years ]
    The hypothesis for this study was that colonoscopy surveillance of a high-risk cohort of patients with rectal bleeding would demonstrate that 10-20% of these patients have pre-malignant colorectal polyps(adenomas) or cancers.


Secondary Outcome Measures :
  1. To detect colorectal cancer early using symptoms based assessment [ Time Frame: 2 years ]
    The long-term impact of identifying at risk patients and patients with early stage cancers may be a reduction in mortality from colorectal cancer in low- and middle- income countries


Biospecimen Retention:   Samples Without DNA
Colonic polyps and colorectal cancer specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Nigerians with rectal bleeding
Criteria

Inclusion Criteria:

  • must be 45-years of age or older
  • has rectal bleeding lasting at least one week
  • has had a complete colonoscopy performed

Exclusion Criteria:

  • Individuals with a personal history of inflammatory bowel disease, colorectal polyps, colorectal adenoma or CRC
  • Individuals with a family history of familial adenomatous polyposis syndromes or other hereditary polyposis syndromes, hereditary nonpolyposis colorectal cancer
  • Individuals with severe comorbidities that were contraindication to colonoscopy
  • Individuals who had a previous history of colectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032874


Locations
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Nigeria
Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
Ile Ife, Osun, Nigeria, 220005
Sponsors and Collaborators
Obafemi Awolowo University Teaching Hospital
Memorial Sloan Kettering Cancer Center, New York, USA
University College Hospital, Nigeria
University of Ilorin Teaching Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olusegun Alatise, Consultant Surgeon/Senior Lecturer, Obafemi Awolowo University Teaching Hospital
ClinicalTrials.gov Identifier: NCT03032874    
Other Study ID Numbers: ERC/2013/02/07
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Each request will be review on their merit by the team and approval of the Ethic and Research Committee that approve the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olusegun Alatise, Obafemi Awolowo University Teaching Hospital:
Colorectal cancer
Polyps
Colonoscopy
Rectal bleeding
Nigeria
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases